Cutaneous Scarring of Scalpel Versus Cautery

NCT00803140 | Terminated

• 1 other identifier: 81818CSSvC
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Cutaneous scarring after elective surgery is a concern for surgeons of all types, perhaps even more so to plastic surgeons. Cautery is often used on the "cut" setting to make or extend incisions; however very few studies have looked at the results of these scars. The investigators' study aims are to compare standard scalpel incisions versus cautery incisions and to objectively compare the resultant scars in a prospective, randomized, controlled fashion.

Conditions

Scars

Keywords

scarring

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the Vancouver Scar Scale

  12 months

Secondary Outcomes (4)

• Visual scar scale done by both the subject and an independent observer

  2 week

• Visual scar scale done by both the subject and an independent observer

  3 months

• Visual scar scale done by both the subject and an independent observer

  6 months

• Visual scar scale done by both the subject and an independent observer

  12 months

Study Arms (2)

Cautery Arm

ACTIVE COMPARATOR

Cautery to make skin incision

Procedure: Cautery vs Active Control Arm (Scalpel)

Scalpel Incision

ACTIVE COMPARATOR

Scalpel to make skin incision

Procedure: Cautery vs Active Control Arm (Scalpel)

Interventions

Cautery vs Active Control Arm (Scalpel) PROCEDURE

Interventions: The cautery used will be the standard operating room monopolar cautery used at our institution. The cautery will be used on a "cut" setting of 20 with a blend setting of zero (pure cut). A standard protected needle tip cautery will be used. A #15 blade carbon steel scalpel blade will be used on ½ of the incision; a cautery device with the above-mentioned settings will be used on the other ½ of the wound. The patient will be randomly assigned to receive the cautery incision on the left or right side. The same surgeon will make all of the skin incisions and perform the skin closures in order to provide as much standardization as possible. The closure will be standardized.

Also known as: bovie

Cautery Arm; Scalpel Incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary, elective panniculectomy.
• Patients must voluntarily be enrolled in the study after informed consent.
• Patients must be in relative good health and have adequate nutrition.
• Patients of all races and genders will be included.
• Patients must agree to refrain from the use of topical scar products during the study period.

You may not qualify if:

• Under the age of 18 years old
• Patients with previous history of hypertrophic or keloid scarring
• Patients presenting for scar revision
• Patients presenting for a non-elective surgery
• Patients with chronic immunosuppression or wound healing problems
• Currently taking medications that interfere with wound healing such as corticosteroids, anti-coagulants (aspirin or NSAIDs), vasoconstricting agents (adrenaline or ergotrate), anti-cancer drugs, or colchicine for gout,
• Use of any tobacco products

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead

Study Sites (1)

Scott and White Hospital and Clinic

Temple, Texas, 76508, United States

Location

Related Publications (6)

• Nguyen DQ, Potokar T, Price P. A review of current objective and subjective scar assessment tools. J Wound Care. 2008 Mar;17(3):101-2, 104-6. doi: 10.12968/jowc.2008.17.3.28666.

  PMID: 18376650 BACKGROUND

• van Zuijlen PP, Angeles AP, Kreis RW, Bos KE, Middelkoop E. Scar assessment tools: implications for current research. Plast Reconstr Surg. 2002 Mar;109(3):1108-22. doi: 10.1097/00006534-200203000-00052.

  PMID: 11884845 BACKGROUND

• Papay FA, Stein J, Luciano M, Zins JE. The microdissection cautery needle versus the cold scalpel in bicoronal incisions. J Craniofac Surg. 1998 Jul;9(4):344-7. doi: 10.1097/00001665-199807000-00010.

  PMID: 9780929 BACKGROUND

• Sheikh B. Safety and efficacy of electrocautery scalpel utilization for skin opening in neurosurgery. Br J Neurosurg. 2004 Jun;18(3):268-72. doi: 10.1080/02688690410001732715.

  PMID: 15327229 BACKGROUND

• Molgat YM, Pollack SV, Hurwitz JJ, Bunas SJ, Manning T, McCormack KM, Pinnell SR. Comparative study of wound healing in porcine skin with CO2 laser and other surgical modalities: preliminary findings. Int J Dermatol. 1995 Jan;34(1):42-7. doi: 10.1111/j.1365-4362.1995.tb04379.x.

  PMID: 7896488 BACKGROUND

• Middleton WG, Tees DA, Ostrowski M. Comparative gross and histological effects of the CO2 laser, Nd-YAG laser, scalpel, Shaw scalpel and cutting cautery on skin in rats. J Otolaryngol. 1993 Jun;22(3):167-70.

  PMID: 8371327 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raman C Mahabir, MD

  Scott and White Hospital & Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 5, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)